Working… Menu

Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613807
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Eli Lilly and Company
Information provided by (Responsible Party):
Lois Jovanovic, MD, Sansum Diabetes Research Institute

Brief Summary:
Humalog® Mix50/50TM administered as 3 injections daily is equivalent to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control, but may have some advantages due to increased ease of use.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Drug: Insulin LISPRO Drug: Insulin, Long-Acting and Insulin LISPRO Phase 4

Detailed Description:

Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.

Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over combination rapid-acting plus NPH insulin because it involves fewer injections, and those injections are associated with mealtime. The potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes
Study Start Date : October 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mix 50/50
3 doses of Mix 50/50 at mealtime
Drug: Insulin LISPRO
Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history.
Other Name: Humalog® Mix50/50™

Active Comparator: Usual insulin regimen
3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime
Drug: Insulin, Long-Acting and Insulin LISPRO
Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.
Other Names:
  • Humalin N(r)
  • Humalog (r)

Primary Outcome Measures :
  1. Fasting self-monitored blood glucose measurements [ Time Frame: Pregnancy (approximately 28 weeks) ]
    Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by fasting glucose measurements.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pregnant and at least 13 weeks gestation
  • Diagnosed with gestational diabetes mellitus
  • Failed diet therapy

Exclusion Criteria:

  • <18 years old or over 45 years old
  • urine dipstick >2+ protein
  • blood pressure >140/80 mmHg
  • hematocrit <30%
  • refusal to take insulin
  • inability to understand instructions or to consent to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613807

Sponsors and Collaborators
Sansum Diabetes Research Institute
Eli Lilly and Company
Layout table for investigator information
Principal Investigator: Lois Jovanovic, MD Sansum Diabetes Research Institute

Layout table for additonal information
Responsible Party: Lois Jovanovic, MD, Chief Scientific Officer, Sansum Diabetes Research Institute Identifier: NCT01613807     History of Changes
Other Study ID Numbers: SDRI 08-01
F3Z-US-X031 ( Other Identifier: Eli Lilly and Company )
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by Lois Jovanovic, MD, Sansum Diabetes Research Institute:
gestational diabetes mellitus
insulin analogues in pregnancy
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Insulin Lispro
Insulin, Isophane
Biphasic Insulins
Isophane insulin, insulin lispro drug combination 50:50
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs